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Prior authorization is a check run by some insurance companies or third-party payers in the United States before they will agree to cover certain prescribed medications or medical procedures. [1] There are a number of reasons that insurance providers require prior authorization, including age, medical necessity, the availability of a generic ...
Prior authorization (PA) is a tool we use to help manage these costs. Even more importantly, they’re a safety measure. Our goal is to ensure our members have the right drug, the right dose, for ...
The FDA requires nonclinical laboratory studies on new drugs, food additives, and chemicals to assess their safety and potential effectiveness in humans in compliance with 21 CFR Part 58, Good Laboratory Practice for Nonclinical Studies under the Federal Food Drug and Cosmetic Act and Public Health Service Act. [16]
Preclinical development. In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Institutional review board. An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee at an institution that applies research ethics by reviewing the methods proposed for research involving human subjects, to ensure that the projects are ...
However, Elizabeth Kaplan, an expert on health law and policy at Harvard Law School, said the new guidance’s wording might provide insurers leeway to require prior authorization and charge ...
Medical prescription. A prescription, often abbreviated ℞ or Rx, is a formal communication from a physician or other registered healthcare professional to a pharmacist, authorizing them to dispense a specific prescription drug for a specific patient. Historically, it was a physician's instruction to an apothecary listing the materials to be ...
Pharmaceutical policy. Pharmaceutical policy is a branch of health policy that deals with the development, provision and use of medications within a health care system. It embraces drugs (both brand name and generic), biologics (products derived from living sources, as opposed to chemical compositions), vaccines and natural health products .